MAUDE Adverse Event Report: ABBOTT MEDICAL AMPLATZER SEPTAL OCCLUDER; TRANSCATHETER SEPTAL OCCLUDER

Catalog Number	9-ASD-038
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Cardiac Tamponade (2226); Pericardial Effusion (3271); Heart Failure/Congestive Heart Failure (4446)
Date of Event	08/17/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The article, "late erosion of amplatzer septal occluder device 9 years after the implantation.A case report.", was reviewed.The article presented a case study of a 50-year-old female with an atrial septal defect (asd).It was reported that on an unknown date, a 38mm amplatzer septal occluder (aso) was implanted to occlude an atrial septal defect with a maximum diameter of 29mm.It was later reported 9 years later, the patient presented at the emergency room with symptoms of cardiogenic shock.Transthoracic echocardiography revealed a large pericardial effusion with tamponade physiology.A decision was made to perform emergency pericardiocentesis and 700 ml of fluid was drained and the patient was stabilized.The patient was later admitted for surgery to explant the 38mm aso for suspected cardiac erosion.During procedure, a perforation was discovered in the roof of the left atrium which was surgically closed.The asd was repaired with a pericardial patch after explant of the 38mm aso.The patient status was reported as stable.The article concluded diagnosis and treatment of cardiac erosion are not always easy.It may occur even a long time after the placement of the device and in these cases, a level of clinical suspicion is demanded.The surgical repair may also be extremely challenging.On the other hand, cardiologists should consider referring patients with asd for surgery in the first place when a number of risk factors are present.[the primary and corresponding author was nikolaos koumallos, department of cardiac surgery, hippokration general hospital, athens, greece, with corresponding email: koumallosn@yahoo.Gr].
Additional Manufacturer Narrative
An event of erosion of an amplatzer septal occluder nine years after implant of the device was reported through a literature article.Information from the article indicated a larger occluder when compared to the defect size was implanted and the patient had an absent aortic rim which are risk factors for device erosion.Because of this, the authors believed the defect should have been treated surgically originally.There is no indication of a product quality issue with regards to manufacture, design, or labeling.

• Brand Name: AMPLATZER SEPTAL OCCLUDER
• Common Device Name: TRANSCATHETER SEPTAL OCCLUDER
• Manufacturer (Section D): ABBOTT MEDICAL; 5050 nathan lane n; plymouth MN 55442
• Manufacturer (Section G): ABBOTT MEDICAL REG# 2135147; 5050 nathan ln n; plymouth MN 55442
• Manufacturer Contact: karen krouse ; 5050 nathan lane n; plymouth, MN 55442 ; 6517565400
• MDR Report Key: 17720284
• Report Number: 2135147-2023-03918
• Device Sequence Number: 7163203
• Product Code: MLV
• UDI-Device Identifier: 00811806010267
• UDI-Public: 00811806010267
• Combination Product (Y/N): N
• Initial Reporter Country: GR
• PMA/510(K) Number: P000039
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: 9-ASD-038
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/17/2023
• Initial Report FDA Received Date: 09/11/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Life Threatening; Required Intervention; Hospitalization
• Patient Age: 50 YR
• Patient Sex: Female